Thoracic DiseasesPhase 2NCT05982639
Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
A Phase 2 study testing two lung ventilation and one lung ventilation in people with Thoracic Diseases and Surgery, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to compare in patients undergoing thoracic procedures the lung inflammatory response in on one-lung ventilation and two-lung ventilation strategies The main question to answer is: Lung inflammation differs when comparing one to two-lung ventilation strategies during the procedure?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Diseases, Surgery
- What is being tested?
- two lung ventilation and one lung ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2023to 1 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of pleural or mediastinal pathology that requires diagnostic or therapeutic surgical intervention;
- Written consent to participate
Who cannot join
- Pregnant women;
- Patients on mechanical ventilation prior to the procedure;
- Patients classified by the American Society of Anesthesiology (ASA) as class 4;
- Patients with subpulmonary or diaphragmatic pathologies, where it is believed that the two pulmonary technique is superior;
- Impossibility of using a double-lumen tube or difficult intubation;
- Patient does not support one-lung ventilation;
- Patient with previous lung resection surgery
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare in patients undergoing thoracic procedures the lung inflammatory response in on one-lung ventilation and two-lung ventilation strategies The main question to answer is:
- Lung inflammation differs when comparing one to two-lung ventilation strategies during the procedure? Participants will be divided in the classic one lung ventilation or two lung ventilation (using pneumothorax with CO2) and different biomarkers of lung inflammation will be measured after procedures.
- Conditions
- Thoracic Diseases, Surgery
- Being tested
- two lung ventilation, one lung ventilation
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two lung ventilationProcedure or surgery
The intervention do not involve a drug or device. It will be compared two different approaches to ventilate the lungs during the procedure . In this arm both lungs will be ventilated inserting a disposable trocar into the pleural cavity, and insufflating CO2 into the thoracic cavity via an insufflator. The insufflation pressure and the flow rate will be set as 8 mmHg and 10 l.min-1, of the cavity with CO2. The insufflator will be adjusted for cavity pressure in 8mmHg and flow of 10L/min.
one lung ventilationProcedure or surgery
In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| one-lung ventilation | Other | Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube. Receives: Procedure: one lung ventilation |
| two-lung ventilation and use of pneumothorax with CO2. | Experimental | Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax Receives: Procedure: two lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoalveolar lavage fluid (BALF) levels of IL-6
It will be compared the levels of IL-6 in the BALF collected immediately before and after the thoracic procedure
Measured: at a maximum 2 hours after the end of the thoracic procedure
Secondary outcomes (6)
Bronchoalveolar lavage fluid (BALF) levels of IL-8
It will be compared the levels of IL-8 in the BALF collected immediately before and after the thoracic procedure
Measured: at a maximum 2 hours after the end of the thoracic procedure
Bronchoalveolar lavage fluid (BALF) levels of IL-1
It will be compared the levels of IL-1 in the BALF collected immediately before and after the thoracic procedure
Measured: at a maximum 2 hours after the end of the thoracic procedure
Bronchoalveolar lavage fluid (BALF) levels of TNF
It will be compared the levels of TNF in the BALF collected immediately before and after the thoracic procedure
Measured: at a maximum 2 hours after the end of the thoracic procedure
Bronchoalveolar lavage fluid (BALF) levels of oxidative stress
It will be compared the levels of malondialdehyde equivalents in the BALF collected immediately before and after the thoracic procedure
Measured: at a maximum 2 hours after the end of the thoracic procedure
Post-procedure pulmonary complications
Composite outcome of associated pulmonary complications including pneumonia, re-expansion edema and postoperative non-re-expansion of the lung
Measured: Until hospital discharge
Systemic levels of inflammatory and oxidative markers
Plasma levels of IL-6, IL-8, IL-1, TNF and malondialdehyde equivalents
Measured: at a maximum 2 hours after the end of the thoracic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start20 Jul 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Investigators
- Eduardo Balleter, MD, Principal investigator, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982639
- Sponsor's protocol ID
- Lung inflammation trial
- Status last verified
- May 2024
- First submitted
- 20 Jul 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial
- ClinicalTrials.gov ID
- NCT05982639
- Acronym / sponsor ID
- Lung inflammation trial
- Conditions
- Thoracic Diseases, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare in patients undergoing thoracic procedures the lung inflammatory response in on one-lung ventilation and two-lung ventilation strategies The main question to answer is:
- Lung inflammation differs when comparing one to two-lung ventilation strategies during the procedure? Participants will be divided in the classic one lung ventilation or two lung ventilation (using pneumothorax with CO2) and different biomarkers of lung inflammation will be measured after procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-lung ventilation | Other | Procedure: one lung ventilationUsual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube. |
| two-lung ventilation and use of pneumothorax with CO2. | Experimental | Procedure: two lung ventilationTwo lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of pleural or mediastinal pathology that requires diagnostic or therapeutic surgical intervention;
- Written consent to participate
Key exclusion criteria (7 listed)
- Pregnant women;
- Patients on mechanical ventilation prior to the procedure;
- Patients classified by the American Society of Anesthesiology (ASA) as class 4;
- Patients with subpulmonary or diaphragmatic pathologies, where it is believed that the two pulmonary technique is superior;
- Impossibility of using a double-lumen tube or difficult intubation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two lung ventilationThe intervention do not involve a drug or device. It will be compared two different approaches to ventilate the lungs during the procedure . In this arm both lungs will be ventilated inserting a disposable trocar into the pleural cavity, and insufflating CO2 into the thoracic cavity via an insufflator. The insufflation pressure and the flow rate will be set as 8 mmHg and 10 l.min-1, of the cavity with CO2. The insufflator will be adjusted for cavity pressure in 8mmHg and flow of 10L/min. | Procedure or surgery | two-lung ventilation and use of pneumothorax with CO2. |
| one lung ventilationIn this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube | Procedure or surgery | one-lung ventilation |
Primary outcome
Bronchoalveolar lavage fluid (BALF) levels of IL-6
Time frame: at a maximum 2 hours after the end of the thoracic procedure
It will be compared the levels of IL-6 in the BALF collected immediately before and after the thoracic procedure
6 secondary outcomes
Bronchoalveolar lavage fluid (BALF) levels of IL-8
Time frame: at a maximum 2 hours after the end of the thoracic procedure
Bronchoalveolar lavage fluid (BALF) levels of IL-1
Time frame: at a maximum 2 hours after the end of the thoracic procedure
Bronchoalveolar lavage fluid (BALF) levels of TNF
Time frame: at a maximum 2 hours after the end of the thoracic procedure
Bronchoalveolar lavage fluid (BALF) levels of oxidative stress
Time frame: at a maximum 2 hours after the end of the thoracic procedure
Post-procedure pulmonary complications
Time frame: Until hospital discharge
Systemic levels of inflammatory and oxidative markers
Time frame: at a maximum 2 hours after the end of the thoracic procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Balleter, MD principal investigator
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing two lung ventilation and one lung ventilation in people with Thoracic Diseases and Surgery, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchoalveolar lavage fluid (BALF) levels of IL-6 (time frame: at a maximum 2 hours after the end of the thoracic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.